The Food and Drug Administration on Tuesday granted permission for emergency use to a Covid-19 treatment that combines two monoclonal antibody drugs.
The approval of the treatment, manufactured by drugmaker Eli Lilly, gives doctors another option for patients with Covid-19 who are not yet sick enough to be admitted to hospital, but who are at risk of becoming seriously ill. word. But even though such therapies were boosted by then-President Trump and several other politicians who took them while ill with Covid-19, the drugs were surprisingly underused in many places – even during hospitalizations through the fall and winter. has risen.
It is important that researchers are hopeful about preliminary data suggesting that the new combination therapy will be better able to combat new virus variants compared to a similar treatment already in use. This can make the new combination therapy very valuable as the new variants take hold.
The newly approved therapy combines the company’s medicine known as bamlanivimab – approved in November and used for high-risk Covid-19 patients – with a second drug known as etesevimab. Both consist of artificially synthesized copies of the antibodies that are naturally generated when an immune system fights infection.
“With the risk of resistance emerging as different strains of the virus develop, bamlanivimab and etesevimab together may allow efficacy against a wider range of natural SARS-CoV-2 variants as these new strains spread around the world,” said Dr. Daniel Skovronsky. , Said the chief scientist of Eli Lilly.
Eli Lilly said it would produce up to 1 million doses of vesimab mid-year, with the help of drugmaker Amgen. The company said it now has 100,000 doses of meal vimab ready and will have 150,000 doses by the end of March.
The federal government has agreed to buy nearly 1.5 million doses of bamlanivimab. The company has already delivered hundreds of thousands of doses, and the rest will be delivered by the end of March. More than 532,000 doses of bamlanivimab have been shipped to states and other jurisdictions.
Another monoclonal antibody combination treatment, made by Regeneron, has also been approved in the United States. Nearly 100,000 doses of the treatment were shipped.
In the results of clinical trials released last month, it was likely that high-risk patients with Covid-19 who received Eli Lilly combination therapy would end up in hospital significantly less than those who received placebo. No patients who received the combination therapy were killed.
The FDA said in a news release that combination therapy may have a significant advantage over bamlanivimab alone – a reduced risk for so-called resistant variants in patients treated with the treatment. The detection of such variants is a sign that virus may evade treatment. The agency said the combination therapy “may protect against treatment failure if a patient is infected with a bamlanivimab-only SARS-CoV-2 viral variant,” although the question has not yet been studied in clinical trials. not.
The combination therapy should be administered by a healthcare provider through an intravenous infusion lasting up to 21 minutes. On Tuesday, the FDA said that bamlanivimab alone can now be administered for a period of as short as 16 minutes, from an hour when the treatment was first approved.
That long infusion time is one of the reasons why monoclonal antibody drugs are no longer widely used in some places. Patients and their families also struggled to access the therapies. Some hospitals are too overwhelmed to prioritize drugs. And some doctors have been reluctant to embrace them, saying they want to see more evidence from clinical trials supporting the use of the drug.